Low-friction sealing devices

ABSTRACT

Aspects herein relate to a low-friction septum for providing a leak-resistant seal for use in a vascular access device. In an embodiment, a device for vascular access hemostasis is included having an enclosure defining a cavity and configured to at least partially receive a medical device. The device can include a first seal portion and a second seal portion, the cavity disposed between the first seal portion and the second seal portion. The device can include a barrel in structural communication with the second seal portion, the second seal portion including a septum seal. The second seal portion can define two or more discrete portions, each separated by one or more split lines. The discrete portions can include a mating surface to interface with mating surfaces of other discrete portions. The mating surface can include a surface topology including raised portions and depressions. Other embodiments are also included herein.

This application is a continuation application of U.S. patentapplication Ser. No. 15/838,677, filed Dec. 12, 2017, now U.S. Pat. No.10,758,719, issued Sep. 1, 2020, which claims the benefit of U.S.Provisional Application No. 62/434,785, filed Dec. 15, 2016, thecontents of which are herein incorporated by reference.

FIELD

Aspects herein relate to a low-friction sealing device for providing aleak-resistant seal for use in a vascular access device.

BACKGROUND

When interventional catheter devices are inserted into the vascularsystem, the physician usually starts with a needle stick, followed bydilating the artery in order to insert an introducer sheath device thatis left in place for the duration of the procedure. This introducersheath acts as the main conduit for entry of subsequent therapeutic ordiagnostic devices.

In most instances, these introducer sheaths contain a hemostaticcomponent that restricts back-flow of blood from the artery. Thesehemostasis seals are generally passive and provide sealing around thecatheter devices and guide wires that are used during the procedure. Insome cases, hemostasis seals can include a septum structure or seal,though which a device such as a guide wire or other medical devicecomponent is inserted in order to pass through the hemostasis seal.

SUMMARY

Aspects herein relate to a low-friction sealing devices for providing aleak-resistant seal for use in a vascular access device. In anembodiment a device for vascular access hemostasis is included. Thedevice can include an enclosure configured to at least partially receivea medical device, the enclosure defining a cavity. The device caninclude a first seal portion and a second seal portion. The cavity canbe disposed between the first seal portion and the second seal portion.The device can include a barrel in structural communication with thesecond seal portion. The second seal portion can include a septum seal.The second seal portion can define two or more discrete portions, eachseparated from one another by one or more split lines. The discreteportions can each include a mating surface configured to interface withmating surfaces of other discrete portions. The mating surface caninclude a surface topology including a plurality of raised portions anddepressions.

In an embodiment a sealing device is included. The sealing device caninclude a device enclosure defining a cavity. The device enclosure canbe configured to compressively interface with a housing. The sealingdevice can include a first seal portion in communication with the deviceenclosure, the first seal portion defining an opening. The sealingdevice can include a second seal portion in communication with thedevice enclosure. The second seal portion can define two or morediscrete portions separated from one another by a split along a splitplane. The discrete portions can each include a mating surface tointerface with mating surfaces of other discrete portions, the matingsurface having a surface topology including a plurality of raisedportions and depressions.

In an embodiment a method of making a sealing device is included. Themethod can include obtaining an enclosure configured to at leastpartially receive a medical device, the enclosure defining a cavity andhaving a first seal portion and a second septum seal portion. The cavitycan be disposed between the first seal portion and the second septumseal portion. The method can further include forming a split in thesecond seal portion, the split defining discrete portions eachcomprising a mating surface to interface with mating surfaces of otherdiscrete portions. The mating surface can include a surface topologyincluding a plurality of raised portions and depressions.

This summary is an overview of some of the teachings of the presentapplication and is not intended to be an exclusive or exhaustivetreatment of the present subject matter. Further details are found inthe detailed description and appended claims. Other aspects will beapparent to persons skilled in the art upon reading and understandingthe following detailed description and viewing the drawings that form apart thereof, each of which is not to be taken in a limiting sense. Thescope herein is defined by the appended claims and their legalequivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects herein can be more completely understood in consideration of thefollowing detailed description of various embodiments in connection withthe accompanying drawings, in which:

FIG. 1 is a cross-sectional view of an example hemostasis sealing deviceconsistent with the technology disclosed herein.

FIG. 2 is a perspective view of an example hemostasis sealing deviceconsistent with the technology disclosed herein.

FIG. 3 is a perspective view of another example hemostasis sealingdevice consistent with the technology disclosed herein.

FIG. 4 is a cross-sectional view of the hemostasis sealing device ofFIG. 3 .

FIG. 5 is another cross-sectional view of the hemostasis sealing deviceof FIG. 3 .

FIG. 6 is a perspective view of another example hemostasis sealingdevice consistent with the technology disclosed herein.

FIG. 7 is a cross-sectional view of the hemostasis sealing device ofFIG. 6 .

FIG. 8 is a perspective view of a hemostasis sealing device inaccordance with various other embodiments.

FIG. 9 is a cross-sectional view of the hemostasis sealing device ofFIG. 8 .

FIG. 10 is a cross-sectional view of a hemostasis sealing device inaccordance with various embodiments.

FIG. 11 is a plan view of the distal end of a hemostasis sealing devicein accordance with various embodiments herein.

FIG. 12 is a plan view of the distal end of a hemostasis sealing devicein accordance with various embodiments herein.

FIG. 13 is a plan view of the distal end of a hemostasis sealing devicein accordance with various embodiments herein.

FIG. 14 is a plan view of the distal end of a hemostasis sealing devicein accordance with various embodiments herein.

FIG. 15 is a cross-sectional view of a hemostasis sealing device inaccordance with various embodiments herein.

FIG. 16 is a view of exemplary surface topologies.

FIG. 17 is an illustration of an exemplary topology including exemplarypeaks and valleys.

These drawings are to be considered general representations of someembodiments, and it will be appreciated that they are not drawn toencompass all embodiments, nor are they always drawn to scale. Whileaspects herein are susceptible to various modifications and alternativeforms, specifics thereof have been shown by way of example and drawings,and will be described in detail. It should be understood, however, thatthe scope herein is not limited to the particular embodiments described.On the contrary, the intention is to cover modifications, equivalents,and alternatives falling within the spirit and scope of that describedherein.

DETAILED DESCRIPTION

Hemostasis valves need to provide for the passage of vascular accesscomponents and medical devices while also providing a sealing function.The insertion of vascular access components and/or medical devices(inserted components) into a hemostasis valve can be hindered byfriction between the inserted components and surfaces within thehemostasis valve that the inserted components contact as they inserted.Excess friction can undesirably increase the amount of force required toinsert components into the hemostasis valve.

Embodiments herein provide for low-friction hemostasis seal structuresand low-friction portions thereof, such as low-friction septums, toreduce the amount of force required to insert a vascular accesscomponent and or medical device into a hemostasis seal structure.

In some embodiments, devices herein can include a hydrophilic coatingproviding lubricious properties to a first seal portion and/or areas ofthe device adjacent to the first seal portion in order to reduce thefriction and insertion force required to insert a device through thefirst seal portion. In various embodiments, hydrophilic coatings canalso be disposed over other portions of the hemostasis sealing device.

In some embodiments, devices herein can include a surface topology withraised portions and depressions reducing the contact area between asecond seal portion and a device passing there through, thereby reducingthe friction and insertion force required to insert a device through thesecond seal portion.

In some embodiments, the first seal portion can be a hole seal or a ringseal, while the second seal portion can be a split, septum seal. Thehemostasis sealing device can include structural elements that areconfigured to structurally support the second seal portion for sealing.In a variety of embodiments, the second seal portion is held incompression by a housing that compressively interfaces with thehemostasis sealing device. In such an embodiment, support ribs can be incompressive communication with the second seal portion. The split of thesecond seal portion can be an axial split offset from the support ribs.In some implementations a barrel extends from the second seal portion toinhibit seal inversion or misalignment.

An example embodiment of such a hemostasis sealing device is shown inFIG. 1 . The hemostasis sealing device 100 is disposed in a housing 200and has a device enclosure 120 in communication with a first sealportion 110 on a support ring 150, a second seal portion 130, and abarrel 140. The housing 200 can be an introducer sheath, but could beanother device that is generally rigid and defines a passageway 210extending from the proximal end 214 of the housing 200 to a distal end212 of the housing 200.

The hemostasis sealing device 100 can be configured to provide a fluidseal for vascular access devices and simultaneously allowing translationor movement of a guide wire while providing a fluid seal there-around.The hemostasis sealing device 100 can be constructed of a variety ofmaterials such as, for example, silicone rubber in the range of 10-60Shore A durometer. In another example, the hemostasis sealing device 100can be constructed so as to contain nitinol elements. Those having skillin the art will recognize that the hemostasis sealing device 100 can beconstructed of various thermoplastic elastomers, and combinationsthereof, available and known.

The hemostasis sealing device 100 is configured to be received by theproximal end 214 of the housing 200. In at least one embodiment thehemostasis sealing device 100 is in compression upon being received bythe housing 200. In one embodiment the compression of the hemostasissealing device 100 is in the range of 0-5% of the diameter of the sealbody. This compression allows the hemostasis sealing device 100 to befirmly held within the housing 200.

The hemostasis sealing device 100 has a device enclosure 120 defining adevice cavity 122 and, as mentioned above, has the first seal portion110 and the second seal portion 130. The first seal portion 110 can beconfigured to provide a seal for a medical device passing into thedevice cavity 122, such as a vascular access device, and the second sealportion 130 can be configured to provide a seal for a guide wire. Thedevice cavity 122 can be sized to receive at least a portion of themedical device.

In this particular embodiment, the support ring 150 has a radial flange152 and is received by a ring receptacle 220 defined by the housing 200.In some embodiments, the support ring 150 will be relatively rigidcompared to some portions of the hemostasis sealing device 100. An outerannular surface 124 of the hemostasis sealing device 100 is received bythe proximal end 214 of the passageway 210 of the housing 200. In atleast one embodiment, the housing 200 exerts compressive force on theouter annular surface 124 of the hemostasis sealing device 100.

The first seal portion 110 can be elastomeric and defines a first sealopening 112 that is sized to seal around the medical device passingthere-through. In one embodiment, the first seal portion 110 is asealing hole. In another embodiment, the first seal portion 110 is asealing ring. Typically the first seal opening 112 defined by the firstseal portion 110 is sized in the range of 0.2-0.4 times the diameter ofthe largest device size that is to be inserted through a given seal. Forinstance, for a 20 Fr device (0.260 in. diameter), the first sealopening 112 size would be in the range of 0.052-0.104 in. in diameter.

The second seal portion 130 is similarly elastomeric to the first sealportion 110 and defines a split 102 there-through. The split 102 can beaxial relative to the second seal portion 130, and can also be axialrelative to the hemostasis sealing device 100 itself. In a variety ofembodiments, the second seal portion 130 has a thickness in the range of0.005-0.020 inches and a diameter in the range of 0.9-1.3 times thediameter of the guide wire to be used. Given the size differentialbetween the first seal portion 110 and the second seal portion 130, inthe current embodiment, the cross section of the device cavity 122generally tapers towards the second seal portion 130. Those having skillin the art will recognize that the second seal portion 130 can beconsistent with a split septum seal. In a variety of embodiments,structural elements of the hemostasis sealing device 100 are configuredto provide structural support to the second seal portion 130. As oneexample, the compression fit between the hemostasis sealing device 100and the housing 200 compresses the second seal portion 130 at the split102 to be in sealing engagement with a guide wire.

A barrel 140 of the hemostasis sealing device 100 can extend from thesecond seal portion 130. The barrel 140 can be annular and coaxial withthe second seal portion 130. The barrel 140 defines a barrel opening142, a substantial portion of which is cylindrical in shape. The barrel140 can be configured to provide structural support to the second sealportion 130. In at least one embodiment, the barrel 140 prevents thesplit 102 of the second seal portion 130 from becoming misaligned and/orinverted on itself, wherein misalignment and inversion can inhibitcomplete sealing.

FIG. 2 depicts a perspective view of the hemostasis sealing device 100of FIG. 1 . From this view the overall configuration of the split ismore clearly visible and the outer configuration of the device enclosure120 and the support ribs 170 are visible.

The split 102 can be defined from the proximal end 104 of the hemostasissealing device 100, through the barrel 140 and the device enclosure 120,and extending towards the support ring 150. In a variety of embodimentsthe split 102 does not extend through the support ring 150 or the firstseal portion 110. In a variety of implementations, it can be desirablefor the hemostasis sealing device 100 to allow passage of large-boredevices, and the split 102 defined by the hemostasis sealing device 100can accommodate such a use.

A tapered portion 126 of the device enclosure 120 extends between theouter annular surface 124 of the device enclosure 120 and the barrel140. The tapered portion 126 can correspond with the tapered shape ofthe device cavity 122 and can extend adjacent to the second seal portion130 (See FIG. 1 ). In the current embodiment the tapered portion 126,the annular surface 124, and the barrel 140 are a single cohesive unit.In some embodiments the annular surface 124, the barrel 140, and thetapered portion 126 can be an assembly of multiple components.

In a variety of implementations the hemostasis sealing device 100includes two or more support ribs 170 along the tapered portion 126 ofthe device enclosure 120 in compressive communication with at least aportion of the split 102. As depicted in FIG. 2 , the current embodimenthas four support ribs 170. The support ribs 170 can be configured toprovide structural support to the hemostasis sealing device 100 when thehemostasis sealing device 100 is installed in a housing, such as thehousing depicted in FIG. 1 . The support ribs 170 can provide structuralsupport to the hemostasis sealing device 100 particularly along thesplit 102 to ensure sealing of the second seal portion 130 (visible inFIG. 1 ) despite insertion of a medical device in the device enclosure120.

In the current embodiment, an outer end surface 172 of each support rib170 is coplanar with the outer annular surface 124 of the deviceenclosure 120. As such, the outer annular surface 124 of the deviceenclosure 120, the outer end surface 172 of each support rib 170 isconfigured for compressive interfacing with the inner annular surface240 of the housing 200 (See FIG. 1 ). An inner end 174 of each supportrib 170 contacts the outer surface 144 of the barrel 140, which can beadjacent to the second seal portion 130 (See FIG. 1 ). As such, despiteexpansion forces from the device cavity 122 and the first seal opening112 (See FIG. 1 ) on the hemostasis sealing device 100 upon medicaldevice insertion, reactive compressive forces by the housing 200 areexerted, in part, on the support ribs 170 and transferred to the barrel140 and, therefore, around the second seal portion 130 of the hemostasissealing device 100. Such compressive forces can prevent separation ofthe hemostasis sealing device 100 at least around the second sealportion 130.

It can be desirable to stagger the split 102 defined by the hemostasissealing device 100 relative to the support ribs 170 such that relativelysymmetrical compressive forces are applied about the second seal portion130. In the current embodiment, the support ribs 170 are symmetricalrelative to the split 102. The split 102 is offset from the support ribs170 by about 45 degrees. Other configurations of support ribs relativeto a split defined by a hemostasis sealing device are also possible.

FIG. 3 is a perspective view of another embodiment of a hemostasissealing device consistent with the technology disclosed herein. Similarto the hemostasis sealing device 100 depicted in FIG. 2 , thishemostasis sealing device 300 has a device enclosure 320 with a firstsealing portion and a second sealing portion (not visible in this view).The hemostasis sealing device 100 has a support ring 350 having a flange352 coupled to the device enclosure 320 that has an outer annularsurface 324 and a tapered portion 326. A barrel 340 defining an opening342 is coupled to the tapered portion 326 and support ribs 370 extendalong the tapered portion 326 from the outer annular surface 324 of thedevice enclosure 320 to the outer surface 344 of the barrel 340. A split302 is defined by the hemostasis sealing device 300 from the proximalend 304 of the hemostasis sealing device 300 towards the support ring350. The split 302 can extend through the barrel 340 and the deviceenclosure 320. However, it will be appreciated that in variousembodiments the split is not as broad as shown in FIG. 3 and does notextend through the width of the barrel 340.

FIGS. 4 and 5 are cross-sectional views consistent with the hemostasissealing device 300 of FIG. 3 , as notated on FIG. 3 . Specifically, FIG.4 is a cross-sectional view of the hemostasis sealing device 300 throughopposing support ribs 370. FIG. 5 is a cross-sectional view of thehemostasis sealing device 300 along the split 302 (See FIG. 3 )revealing a split-defining surface 306 of the hemostasis sealing device300 that is adjacent to the split 302 (FIG. 3 ). In FIG. 5 it is visiblethat the split-defining surface 306 and, therefore, the split 302itself, extends from the proximal end 304 of the hemostasis sealingdevice 300, through the barrel 340 and the device enclosure 320 to thesupport ring 350. In the current embodiment the support ring 350 doesnot define any portion of the split 302.

Visible in FIG. 5 , the annular surface 324 of the device enclosure 320has a tapered portion 326 that couples to the barrel 340. Similar to theembodiment depicted in FIGS. 1-2 , the support ribs 370 of thehemostasis sealing device 300 of FIGS. 3-5 are disposed along thetapered portion 326 and each have an outer end surface 372 that issubstantially coplanar with the outer annular surface 324 of the deviceenclosure 320 and an inner end 374 adjacent to the second sealingportion 330. The inner end 374 of each rib 370 generally meets the outersurface 344 of the barrel 340. There are four support ribs 370 in thisparticular embodiment, which are staggered 45 degrees from the split302.

In the embodiment depicted in FIGS. 4 and 5 , the barrel opening 342defined by the barrel 340 is at least partially tapered from the secondseal portion 330 to the proximal end 304 of the hemostasis sealingdevice 300. Such a configuration can help prevent inversion of thesecond seal portion 330. Those having skill in the art will appreciateother configurations that could have similar advantages regarding thesecond seal portion 330.

FIG. 6 is a perspective view of another embodiment of a hemostasissealing device consistent with the technology disclosed herein. FIG. 7is a cross-sectional view of the hemostasis sealing device 400 of FIG. 6. In this embodiment a first seal portion 410 and the second sealportion 430 are manufactured as separate components and are coupled toform a cohesive unit. The first seal portion 410 is defined by a supportring 450 having a flange 452 that is configured to engage a deviceenclosure 420 defining the second seal portion 430. A barrel 440 extendsfrom the device enclosure 420 and is configured to provide structuralsupport to the second seal portion 430. Support ribs 470 areadditionally configured to provide structural support to the second sealportion 430. Each support rib 470 has an outer end surface 472 that issubstantially coplanar with the outer annular surface 424 of the deviceenclosure 420 and an inner end 474 in compressive communication with thesecond seal portion 430. Each support rib 470 is configured to exertcompressive force on the second seal portion 430, through the barrelouter surface 442, upon insertion of the hemostasis sealing device 400in a housing such as an introducer sheath.

In the current embodiment the first seal portion 410 has a radial lip414 extending into the device cavity 422 that at least partially definesa first seal opening 412. The radial lip 414 can be configured tocontribute to device sealing around a medical device.

The support ring 450 can be coupled to the device enclosure 420 througha variety of ways that will be known in the art. In one embodiment anadhesive is disposed between the support ring 450 and the deviceenclosure 420 to couple the components. In another embodiment thesupport ring flange 452 threadably engages a mating structure 480defined by the device enclosure 420. The mating structure 480 caninclude a mating flange 482 that is configured to be concentric to theflange 452 of the support ring 450. The mating flange 482 can define athreaded surface that is configured to be received by the support ringflange 452. In some embodiments the support ring 450 is configured to bepermanently fixed to the device enclosure 460. In other embodiments thesupport ring 450 is configured to be removably fixed to the deviceenclosure 460. Other configurations will be appreciated by those havingskill in the art.

Referring now to FIG. 8 , a perspective view is shown of a hemostasissealing device in accordance with various other embodiments. Thehemostasis sealing device 800 has a device enclosure 320 with a firstsealing portion and a second sealing portion (not visible in this view).The hemostasis sealing device 800 has a support ring 350 having a flange352 coupled to the device enclosure 320 that has an outer annularsurface 324 and a tapered portion 326. A barrel 340 defining an opening342 is coupled to the tapered portion 326 and support ribs 370 extendalong the tapered portion 326 from the outer annular surface 324 of thedevice enclosure 320 to the outer surface 344 of the barrel 340. A split302 is defined by the hemostasis sealing device 300 from the proximalend 304 of the hemostasis sealing device 300 towards the support ring350. The split 302 can extend through the barrel 340 and the deviceenclosure 320. However, it will be appreciated that in some embodimentsthe split 302 is not nearly as broad as that shown in FIG. 8 .

The hemostasis sealing device includes a constriction ring 802 that isdisposed around the barrel 340. In some embodiments, the constrictionring 802 is disposed around the barrel 340 between the support ribs 370and the proximal end 304.

The constriction ring 802 can interface with the second seal portion tolimit movement of the split, septum seal. The constriction ring 802 canbe formed of various materials. In some embodiments, the constrictionring 802 includes an elastomeric material, such as an elastomericpolymer. In some embodiments, the constriction ring 802 can be formed ofthe same material as the barrel 340. In other embodiments, theconstriction ring 802 and the barrel 340 are formed of two differentmaterials. In some embodiments, the constriction ring 802 can be sizedwith an inner diameter (while unstretched) that is approximately equalto the outer diameter of the portion of the barrel 340 that it directlycontacts. In other embodiments, the constriction ring 802 can be sizedwith an inner diameter (while unstretched) that is slightly smaller thanthe outer diameter of the portion of the barrel 340 that it directlycontacts, such that it exerts a compressive force on the barrel 340continuously.

In some embodiments, the barrel 340 does not include surface features toaid in retaining the constriction ring 802. However, in otherembodiments, the surface of the barrel 340 can define a channel or notchinto which the constriction ring 802 fits. In some embodiments, thebarrel 340 can include a retaining flange on the surface thereof inorder to help retain the constriction ring 802 in position

Referring now to FIG. 9 , a cross-sectional view is shown of thehemostasis sealing device 800 of FIG. 8 . In this view, it can be seenthat the barrel 340 defines a notch (or channel) 904, into which theconstriction ring 802 fits. The notch 904 can be disposed around theouter perimeter of the barrel and can be configured to receive theconstriction ring 802. Referring to now to FIG. 10 , a cross-sectionalview is shown of the hemostasis sealing device 800 of FIG. 8 . Aretaining flange 1008 is disposed on the surface of the barrel 340. Insome cases, the barrel itself can define a retaining flange around theouter perimeter of the barrel. The retaining flange 1008 can be disposedbetween the constriction ring 802 and the proximal end 304.

It will be appreciated that in some embodiments, the hemostasis sealingdevice 800 can include both a notch and a retaining flange.

Although the constriction ring 802 as shown in FIGS. 8-10 issubstantially polygonal in cross-section (and rectangular inparticular), the constriction ring 802 can take on many different shapesin cross-section. For example, the constriction ring 802 can also besquare, non-polygonal (such as circular or oval), irregular, or thelike.

In some embodiments, a method of making a sealing device is included.The method can include obtaining an enclosure configured to at leastpartially receive a medical device. The enclosure can define a cavityand can have a first seal portion and a second seal portion, the cavitydisposed between the first seal portion and the second seal portion. Thesecond seal portion can include a split, septum seal. The method canfurther include disposing a constriction ring around the enclosure, theconstriction ring interfacing with the split, septum seal to limitmovement of the split, septum seal.

In some embodiments, one or more surfaces of the hemostasis sealingdevice can include a surface topology with raised portions anddepressions so that a reduced surface area is presented to anything thatcontacts that portion of the hemostasis sealing device. Reducing thesurface area can reduce the friction of anything contacting the surface.For example, mating surfaces associated with the second seal portion canbe modified to have a surface topology that minimizes the surface areacontacting any device passing through the second seal portion. In thisway the amount of force required to push a device through the secondseal portion can be reduced.

Referring now to FIG. 11 , a plan view as taken from the distal end of ahemostasis sealing device 1100 is shown in accordance with variousembodiments herein. In this view, the hemostasis sealing device 1100 canbe seen to have a radial flange 1152, a tapered portion 1126, a barrel1140, and support ribs 1170, with those elements being consistent withhow they are described according to other embodiments herein. Thehemostasis sealing device 1100 includes a second seal portion 1130. Thesecond seal portion 1130 defines a first discrete portion 1182 and asecond discrete portion 1186 separated from one another by a split line1102 (or cut line or segmentation line) disposed along a split plane.The first discrete portion 1182 includes a mating surface 1184 and thesecond discrete portion 1186 also includes a mating surface 1188. Themating surfaces 1184 and 1188 can interface with each other when thesecond seal portion 1130 is in a closed configuration with nothingpassing there through. The mating surfaces 1184, 1188 can have a surfacetopology including a plurality of raised portions and depressions. Inthis view, the surface topology is represented by a zig-zag line, but itwill be appreciated that many other configurations are possible. Thesurface topology functions to reduce the surface area of the second sealportion 1130 contacting a medical device which is inserted through thesecond seal portion 1130. As such, the surface topology functions toreduce the amount of friction associated with inserting a medical devicethrough the second seal portion.

In some embodiments, the split line (or cut line or segmentation line)may extend beyond the second seal portion. For example, the split linecan also pass through adjoining structures such as the barrel. Thesurface topology does not have to be the same across the entirety of thesplit line. As such, in some embodiments the split line includes one ormore zones with a first topology and one or more zones with a secondtopology that is different than the first topology. However, in otherembodiments the surface topology is uniform across the entirety of thesplit line.

In yet other embodiments the second seal portion 1130 defines a firstdiscrete portion 1182 and a second discrete portion 1186 wherein thefirst discrete portion 1182 and a second discrete portion 1186 canoverlap to form an effective seal. The overlap can include, but is notlimited to, a dovetail overlap such as the surface topologies describedin FIG. 16 .

Referring now to FIG. 12 , a plan view of the distal end of a hemostasissealing device 1100 is shown in accordance with various embodimentsherein. In this embodiment, the split line 1102 extends through thebarrel 1140 and the tapered portion 1126. The split line 1102 includesouter split areas 1204 and an inner split area 1202. The split line 1102can define a first surface topology in the area of the inner split area1202 including raised portions and depressions. The split line 1102 canalso define a different surface topology in the area of the outer splitareas 1204. For example, the split line 1102 can simply have a surfacetopology that is substantially flat in the outer split areas 1204.

In some embodiments, hemostasis sealing devices herein can includemultiple cut lines. Referring now to FIG. 13 , a plan view of the distalend of a hemostasis sealing device 1100 is shown in accordance withvarious embodiments herein. In this view, the hemostasis sealing device1100 includes a first split line 1302 and a second split line 1304.Thus, the second seal portion 1130 defines a four discrete portions,each with mating surfaces and a surface topology with raised portionsand depressions. While first split line 1302 and second split line 1304are shown substantially perpendicular to one another, they can also takeon different angles with respect to one another.

Many different specific numbers of split lines and discrete portions ofthe second seal portion are contemplated herein. In various embodiments1 to 10 split lines can be included forming 2 to 20 discrete portions ofthe second seal portion. Additionally, the multiple split lines canoverlap forming an effective seal.

Referring now to FIG. 14 , a plan view of the distal end of a hemostasissealing device 1100 is shown in accordance with various embodimentsherein. In this view, the hemostasis sealing device 1100 includes afirst split line 1402, a second split line 1404, and a third split line1406. Thus, the second seal portion 1130 defines a three discreteportions, each with mating surfaces and a surface topology with raisedportions and depressions.

In various embodiments, one or more portions of the device can becovered by a hydrophilic layer of material in order to reduce frictionassociated with a medical device contacting such areas when it isinserted in the hemostasis sealing device.

Referring now to FIG. 15 , a cross-sectional view of a hemostasissealing device 1100 in accordance with various embodiments herein isshown. In FIG. 15 , a first seal portion 1510 is shown near the proximalend 1572 of the hemostasis sealing device 1100. The first seal portion1510 includes a sloped portion 1562 that is sloped toward the distalend, forming a frustoconical shape. The sloped portion 1562 includes anouter surface and a hydrophilic layer 1564 disposed on the outersurface. The hydrophilic layer 1564 can function to reduce the frictionassociated with inserting a device through the first seal portion 1510.The first seal portion 1510 can also take on shapes such as a distallyfacing bell shape, a distally facing pyramidal shape, and the like.

The hemostasis sealing device 1100 also includes a second seal portion1130. In this view the split line 1102 dividing the second seal portion1130 is shown on end and therefore the surface topology is not evidentfrom this view. In some embodiments, the second seal portion 1130includes hydrophilic layers 1572 disposed on the mating surfaces of thediscrete portions of the second seal portion 1130. These hydrophiliclayers 1572 can function to reduce the friction associated withinserting a device through the second seal portion 1130.

A device cavity 1522 is disposed inside the device 1100 between thefirst seal portion 1510 and a second seal portion 1130. In someembodiments, a hydrophilic layer 1568 is disposed on a sloped portion1566 of the device lining the device cavity 1522 adjacent the secondseal portion 1130. In some embodiments, a hydrophilic layer 1568 isdisposed on all surfaces of the device facing the device cavity 1522.

It will be appreciated that many different surface topologies arecontemplated herein for the mating surfaces of the discrete portions ofthe second seal portion. The surface topology can function to reduce thesurface area in contact with medical devices inserted into one or moreportions of the hemostasis sealing device

The surface topology can include a plurality of raised portions anddepressions. In some embodiments, the raised portions and depressionscan include a regular pattern of peaks and valleys. The peaks andvalleys can be consistent through at least a portion of the depth of thesplit line such that they form channels passing through the depth of thesplit line.

Referring to now to FIG. 16 , a cross-sectional view is shown of someexemplary surface topologies. The first topology 1602 includes raisedportions and depressions as a series of peaks 1604 and valleys 1606. Thesecond topology 1622 includes raised portions and depressions as aseries of flattened peaks 1624 and flattened valleys 1626. The thirdtopology 1642 includes raised portions and depressions that are rounded.

Referring now to FIG. 17 , an illustration is shown of an exemplarytopology 1702 including exemplary peaks 1704 and valleys 1706 inaccordance with various embodiments herein. The peaks and valleys canhave a pitch 1710 of about 0.01 mm to about 1.0 mm, in the absolute oron average. The vertical distance 1708 between the top of peaks 1704 andthe bottom of valleys 1706 can be about 0.01 mm to about 1.0 mm, in theabsolute or on average.

In various embodiments, a method of making a sealing device is includedherein. The method can include obtaining an enclosure configured to atleast partially receive a medical device, the enclosure defining acavity and having a first seal portion and a second septum seal portion,the cavity disposed between the first seal portion and the second septumseal portion.

The method can further include forming a split in the second sealportion, the split defining discrete portions each comprising a matingsurface to interface with mating surfaces of other discrete portions,the mating surface including a surface topology including a plurality ofraised portions and depressions. It will be appreciated that there arevarious techniques that can be used to form the split.

Hydrophilic Layer Materials

As described above, in various embodiments a hydrophilic and/orlubricious layer of material can be disposed over one or more portionsof the hemostasis sealing device. In some embodiments the hydrophiliclayer of material can be arranged so as to contact any medical devicethat is inserted into the hemostasis sealing device, thereby reducingfriction associated with the insertion of a medical device into thehemostasis sealing device.

Exemplary materials of the hydrophilic and/or lubricious layer caninclude, but are not limited to, lubricious low friction coating suchas, a silicone oil, perfluorinated oils and waxes, optionally withcovalent bonding, to decrease friction. These examples of low frictionand hydrophilic coatings assist in increasing lubricity and decreasingthe generation of particulate.

Examples of other fluorinated low friction coatings include coatingsderived from water soluble fluoropolymers containing a UV-activatablegroup as described in U.S. Pat. No. 8,932,694 (to Rolfes et al.), thedisclosure of which is incorporated herein by reference.

One class of hydrophilic polymers useful as polymeric materials forhydrophilic layers herein formation includes synthetic hydrophilicpolymers. Synthetic hydrophilic polymers that are biostable (i.e., thatshow no appreciable degradation in vivo) are prepared from a suitablemonomer including, but not limited to, acrylic monomers, vinyl monomers,ether monomers, or combinations of any one or more of these types ofmonomers. Acrylic monomers include, but are not limited to,methacrylate, methyl methacrylate, hydroxyethyl methacrylate,hydroxyethyl acrylate, methacrylic acid, acrylic acid, glycerolacrylate, glycerol methacrylate, acrylamide, methacrylamide,dimethylacrylamide (DMA), and one or more of derivatives or mixtures ofany of these. Vinyl monomers include, but are not limited to, vinylacetate, vinylpyrrolidone, vinyl alcohol, and derivatives of any ofthese. Ether monomers include, but are not limited to, ethylene oxide,propylene oxide, butylene oxide, and derivatives of any of these.Examples of polymers formed from these monomers include, but are notlimited to, poly(acrylamide), poly(methacrylamide),poly(vinylpyrrolidone), poly(acrylic acid), poly(ethylene glycol),poly(vinyl alcohol), and poly(HEMA). Examples of hydrophilic copolymersinclude, but are not limited to, methyl vinyl ether/maleic anhydridecopolymers and vinyl pyrrolidone/(meth)acrylamide copolymers. Further,mixtures of one or more or homopolymers or copolymers are used in someexamples for hydrophilic layers.

Other hydrophilic polymer coatings for production of lubricious surfacesinclude, but are not limited to, poly(vinylpyrrolidone) layers with anacrylic acid polymer top coat. The acrylic acid polymer can be in directcontact with the poly(vinylpyrrolidone) layers. The direct contact canallow for hydrogen bonding interactions between thepoly(vinylpyrrolidone) base coat and the acrylic acid polymer top coat.Exemplary lubricious coatings with poly(vinylpyrrolidone) base coat andan acrylic acid polymer top coat are described in U.S. Pat. App. Publn.2016/0175489 (to Babcock et al.).

Examples of some acrylamide-based polymers, such aspoly(N,Ndimethylacrylamide-co-aminopropylmethacrylamide) andpoly(acrylamide-co-N,Ndimethylaminopropylmethacrylamide) are describedin example 2 of U.S. Pat. No. 7,807,750 (Taton et al.), the disclosureof which is incorporated herein by reference.

Other hydrophilic polymers used with the subject matter of thisdisclosure include derivatives of acrylamide polymers with photoreactivegroups. One such representative hydrophilic polymer is thecopolymerization of N-[3-(4-benzoylbenzamido)propyl] methacrylamide(Formula I) with N-(3-aminopropyl)methacrylamide (Formula II) to producethe polymerpoly(N-3-aminopropyl)methacrylamide-co-N-[3-(4-benzoylbenzamido)propyl]methacrylamide(Formula III). The preparation of the polymer is disclosed in Example 1of US Patent Publication 2007/0032882 (to Lodhi, et al.), the fullcontent of which is incorporated herein by reference.

In some embodiments, the hydrophilic polymer includes a vinylpyrrolidone polymer, or a vinyl pyrrolidone/(meth)acrylamide copolymersuch as poly(vinylpyrrolidone-co-methacrylamide). If a PVP copolymer isused, in some examples it includes a copolymer of vinylpyrrolidone and amonomer selected from the group of acrylamide monomers. Exemplaryacrylamide monomers include (meth)acrylamide and (meth)acrylamidederivatives, such as alkyl (meth)acrylamide, as exemplified bydimethylacrylamide, and aminoalkyl (meth)acrylamide, as exemplified byaminopropylmethacrylamide and dimethylaminopropylmethacrylamide. Forexample, poly(vinylpyrrolidone-co-N,N-dimethylaminopropylmethacrylamide)is described in example 2 of U.S. Pat. No. 7,807,750 (Taton et al.).

In one embodiment, the polymers and copolymers as described arederivatized with one or more photoactivatable group(s). Exemplaryphotoreactive groups that can be pendent from biostable hydrophilicpolymer include aryl ketones, such as acetophenone, benzophenone,anthraquinone, anthrone, quinone, and anthrone-like heterocycles. Arylketones herein can specifically include diaryl ketones. Polymers hereincan provide a hydrophilic polymer having a pendent activatablephotogroup that can be applied to the expandable and collapsiblestructure, and can then treated with actinic radiation sufficient toactivate the photogroups and cause covalent bonding to a target, such asthe material of the expandable and collapsible structure. Use ofphoto-hydrophilic polymers can be used to provide a durable coating of aflexible hydrogel matrix, with the hydrophilic polymeric materialscovalently bonded to the material of the expandable and collapsiblestructure.

A hydrophilic polymer having pendent photoreactive groups can be used toprepare the flexible hydrogel coating. Methods of preparing hydrophilicpolymers having photoreactive groups are known in the art. For example,methods for the preparation of photo-PVP are described in U.S. Pat. No.5,414,075 (to Swan et al), the disclosure of which is incorporatedherein by reference. Hydrophilic photo-polyacrylamide polymers such aspoly(acrylamide-co-N-(3-(4-benzoylbenzamido)propyl) methacylamide),“Photo PA”, and derivatives thereof can be used to form hydrophiliclayers in exemplary embodiments of the present disclosure. Methods forthe preparation of photo-polyacrylamide are described in U.S. Pat. No.6,007,833 (to Chudzik et al.), the disclosure of which is incorporatedherein by reference.

Other embodiments of hydrophilic layers include derivatives ofphoto-polyacrylamide polymers incorporating additional reactivemoieties. Some exemplary reactive moieties include N-oxysuccinimide andglycidyl methacrylate. Representative photo-polyacrylamide derivativesincorporating additional reactive moieties includepoly(acrylamide-co-maleic-6-aminocaproicacid-N-oxysuccinimide-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide)andpoly(acrylamide-co-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-glycidylmethacrylate.Additional photo-polyacrylamide polymers incorporating reactive moietiesare described in U.S. Pat. No. 6,465,178 (to Chappa, et al.), U.S. Pat.No. 6,762,019 (to Swan, et al.) and U.S. Pat. No. 7,309,593 (to Ofstead,et al.), the disclosures of which are herein incorporated by reference.

Other embodiments of exemplary hydrophilic layers that includederivatives of photo-polyacrylamide polymers incorporating additionalreactive moieties can be found in U.S. Pat. No. 6,514,734 (to Clapper,et al.), the disclosure of which is incorporated herein by reference inits entirety.

In yet other embodiments, the hydrophilic layer can include derivativesof photo-polyacrylamide polymers incorporating charged moieties. Chargedmoieties include both positively and negatively charged species.Exemplary charged species include, but are not limited to, sulfonates,phosphates and quaternary amine derivatives. Some examples include thenegatively charged species N-acetylatedpoly(acrylamide-co-sodium-2-acrylamido-2-methylpropanesulfonate-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-methoxypoly(ethylene glycol) monomethacrylate. Other negatively charged speciesthat can be incorporated into the hydrophilic layer are described inU.S. Pat. No. 4,973,493 (to Guire et al.), the disclosure of which isincorporated herein by reference in its entirety. Positively chargedspecies can includepoly(acrylamide-co-N-(3-(4-benzoylbenzamido)propyl)methacrylamide)-co-(3-(methacryloylamino)propyl)trimethylammoniumchloride. Other positively charged species that can be incorporated intothe hydrophilic layer are described in U.S. Pat. No. 5,858,653 (to Duranet al.), the disclosure of which is incorporated herein by reference inits entirety.

In another embodiment, the polymers and copolymers as described arederivatized with one or more polymerizable group(s). Polymers withpendent polymerizable groups are commonly referred to as macromers. Thepolymerizable group(s) can be present at the terminal portions (ends) ofthe polymeric strand or can be present along the length of the polymer.In one embodiment polymerizable groups are located randomly along thelength of the polymer.

Exemplary hydrophilic polymer coatings can be prepared using polymergrafting techniques. Polymer grafting techniques can include applying anonpolymeric grafting agent and monomers to a substrate surface thencausing polymerization of the monomers on the substrate surface uponappropriate activation (for example, but not limited to, UV radiation)of the grafting agent. Grafting methods producing hydrophilic polymericsurfaces are exemplified in U.S. Pat. Nos. 7,348,055; 7,736,689 and8,039,524 (all to Chappa et al.) the full disclosures of which areincorporated herein by reference.

Optionally, the coating can include a crosslinking agent. A crosslinkingagent can promote the association of polymers in the coating, or thebonding of polymers to the coated surface. The choice of a particularcrosslinking agent can depend on the ingredients of the coatingcomposition.

Suitable crosslinking agents can include two or more activatable groups,which can react with the polymers in the composition. Suitableactivatable groups can include photoreactive groups as described herein,like aryl ketones, such as acetophenone, benzophenone, anthraquinone,anthrone, quinone, and anthrone-like heterocycles. A crosslinking agentincluding a photoreactive group can be referred to as aphoto-crosslinker or photoactivatable crosslinking agent. Thephotoactivatable crosslinking agent can be ionic, and can have goodsolubility in an aqueous composition. Thus, in some embodiments, atleast one ionic photoactivatable crosslinking agent can be used to formthe coating. The ionic crosslinking agent can include an acidic group orsalt thereof, such as selected from sulfonic acids, carboxylic acids,phosphonic acids, salts thereof, and the like. Exemplary counter ionsinclude alkali, alkaline earths metals, ammonium, protonated amines, andthe like.

Exemplary ionic photoactivatable crosslinking agents include4,5-bis(4-benzoylphenylmethyleneoxy) benzene-1,3-disulfonic acid orsalt; 2,5-bis(4-benzoylphenylmethyleneoxy)benzene-1,4-disulfonic acid orsalt; 2,5-bis(4-benzoylmethyleneoxy)benzene-1-sulfonic acid or salt;N,N-bis[2-(4-benzoylbenzyloxy)ethyl]-2-aminoethanesulfonic acid or salt,and the like. See U.S. Pat. No. 6,077,698 (Swan et al.), U.S. Pat. No.6,278,018 (Swan), U.S. Pat. No. 6,603,040 (Swan) and U.S. Pat. No.7,138,541 (Swan) the disclosures of which are incorporated herein byreference.

Other exemplary ionic photoactivatable crosslinking agents includeethylenebis(4-benzoylbenzyldimethylammonium) dibromide andhexamethylenebis(4-benzoylbenzyldimethylammonium) dibromide and thelike. See U.S. Pat. No. 5,714,360 (Swan et al.) the disclosures of whichare incorporated herein by reference.

In yet other embodiments, restrained multifunctional reagents withphotoactivable crosslinking groups can be used. In some examples theserestrained multifunctional reagents include tetrakis (4-benzoylbenzylether) of pentaerthyritol and the tetrakis (4-benzoylbenzoate ester) ofpentaerthyritol. See U.S. Pat. No. 5,414,075 (Swan et al.) and U.S. Pat.No. 5,637,460 (Swan et al.) the disclosures of which are incorporatedherein by reference.

Additional crosslinking agents can include those having formulaPhoto1-LG-Photo2, wherein Photo1 and Photo2 independently represent atleast one photoreactive group and LG represents a linking groupcomprising at least one silicon or at least one phosphorus atom, whereinthe degradable linking agent comprises a covalent linkage between atleast one photoreactive group and the linking group, wherein thecovalent linkage between at least one photoreactive group and thelinking group is interrupted by at least one heteroatom. See U.S. Pat.No. 8,889,760 (Kurdyumov, et al.), the disclosure of which isincorporated herein by reference. Further crosslinking agents caninclude those having a core molecule with one or more charged groups andone or more photoreactive groups covalently attached to the coremolecule by one or more degradable linkers. See U.S. Publ. Pat. App. No.2011/0144373 (Swan, et al.), the disclosure of which is incorporatedherein by reference.

In some embodiments, the first and/or second crosslinking agent can havea molecular weight of less than about 1500 kDa. In some embodiments thecrosslinking agent can have a molecular weight of less than about 1200,1100, 1000, 900, 800, 700, 600, 500, or 400.

In some embodiments, at least one of the first and second crosslinkingagents comprising a linking agent having formula Photo1-LG-Photo2,wherein Photo1 and Photo2, independently represent at least onephotoreactive group and LG represents a linking group comprising atleast one silicon or at least one phosphorus atom, there is a covalentlinkage between at least one photoreactive group and the linking group,wherein the covalent linkage between at least one photoreactive groupand the linking group is interrupted by at least one heteroatom.

In some embodiments, at least one of the first and second crosslinkingagents comprising a linking agent having a formula selected from:

wherein R1, R2, R8 and R9 are any substitution; R3, R4, R6 and R7 arealkyl, aryl, or a combination thereof; R5 is any substitution; and eachX, independently, is O, N, Se, S, or alkyl, or a combination thereof;

wherein R1 and R5 are any substitution; R2 and R4 can be anysubstitution, except OH; R3 can be alkyl, aryl, or a combinationthereof; and X, independently, are O, N, Se, S, alkylene, or acombination thereof;

wherein R1, R2, R4 and R5 are any substitution; R3 is any substitution;R6 and R7 are alkyl, aryl, or a combination thereof; and each X canindependently be O, N, Se, S, alkylene, or a combination thereof; and

In a particular embodiment, the crosslinking agent can bebis(4-benzoylphenyl) phosphate.

In some embodiments, the photoactivatable crosslinking agent can beionic, and can have good solubility in an aqueous composition, such asthe first and/or second coating composition. Thus, in some embodiments,at least one ionic photoactivatable crosslinking agent is used to formthe coating. In some cases, an ionic photoactivatable crosslinking agentcan crosslink the polymers within the second coating layer which canalso improve the durability of the coating.

Any suitable ionic photoactivatable crosslinking agent can be used. Insome embodiments, the ionic photoactivatable crosslinking agent is acompound of formula I: X1-Y—X2 where Y is a radical containing at leastone acidic group, basic group, or a salt of an acidic group or basicgroup. X1 and X2 are each independently a radical containing a latentphotoreactive group. The photoreactive groups can be the same as thosedescribed herein. Spacers can also be part of X1 or X2 along with thelatent photoreactive group. In some embodiments, the latentphotoreactive group includes an aryl ketone or a quinone.

The radical Y in formula I provides the desired water solubility for theionic photoactivatable crosslinking agent. The water solubility (at roomtemperature and optimal pH) is at least about 0.05 mg/ml. In someembodiments, the solubility is about 0.1 to about 10 mg/ml or about 1 toabout 5 mg/ml.

In some embodiments of formula I, Y is a radical containing at least oneacidic group or salt thereof. Such a photoactivatable crosslinking agentcan be anionic depending upon the pH of the coating composition.Suitable acidic groups include, for example, sulfonic acids, carboxylicacids, phosphonic acids, and the like. Suitable salts of such groupsinclude, for example, sulfonate, carboxylate, and phosphate salts. Insome embodiments, the ionic crosslinking agent includes a sulfonic acidor sulfonate group. Suitable counter ions include alkali, alkalineearths metals, ammonium, protonated amines, and the like.

For example, a compound of formula I can have a radical Y that containsa sulfonic acid or sulfonate group; X1 and X2 can contain photoreactivegroups such as aryl ketones. Such compounds include4,5-bis(4-benzoylphenylmethyleneoxy) benzene-1,3-disulfonic acid orsalt; 2,5-bis(4-benzoylphenylmethyleneoxy)benzene-1,4-disulfonic acid orsalt; 2,5-bis(4-benzoylmethyleneoxy)benzene-1-sulfonic acid or salt;N,N-bis[2-(4-benzoylbenzyloxy)ethyl]-2-aminoethanesulfonic acid or salt,and the like. See U.S. Pat. No. 6,278,018 (to Swan). The counter ion ofthe salt can be, for example, ammonium or an alkali metal such assodium, potassium, or lithium.

In other embodiments of formula I, Y can be a radical that contains abasic group or a salt thereof. Such Y radicals can include, for example,an ammonium, a phosphonium, or a sulfonium group. The group can beneutral or positively charged, depending upon the pH of the coatingcomposition. In some embodiments, the radical Y includes an ammoniumgroup. Suitable counter ions include, for example, carboxylates,halides, sulfate, and phosphate. For example, compounds of formula I canhave a Y radical that contains an ammonium group; X1 and X2 can containphotoreactive groups that include aryl ketones. Such photoactivatablecrosslinking agents include ethylenebis(4-benzoylbenzyldimethylammonium)salt; hexamethylenebis (4-benzoylbenzyldimethylammonium) salt;1,4-bis(4-benzoylbenzyl)-1,4-dimethylpiperazinediium) salt,bis(4-benzoylbenzyl) hexamethylenetetraminediium salt,bis[2-(4-benzoylbenzyldimethylammonio)ethyl]-4-benzoylbenzylmethylammonium salt; 4,4-bis(4-benzoylbenzyl)morpholinium salt;ethylenebis[(2-(4-benzoylbenzyldimethylammonio)ethyl)-4-benzoylbenzylmethylammonium]salt; and 1,1,4,4-tetrakis(4-benzoylbenzyl) piperzinediium salt. SeeU.S. Pat. No. 5,714,360 (to Swan et al.). The counter ion is typically acarboxylate ion or a halide. On one embodiment, the halide is bromide.

In other embodiments, the ionic photoactivatable crosslinking agent canbe a compound having the formula:

wherein X1 includes a first photoreactive group; X2 includes a secondphotoreactive group; Y includes a core molecule; Z includes at least onecharged group; D1 includes a first degradable linker; and D2 includes asecond degradable linker. Additional exemplary degradable ionicphotoactivatable crosslinking agents are described in US PatentApplication Publication US 2011/0144373 (Swan et al., “Water SolubleDegradable Crosslinker”), the disclosure of which is incorporated hereinby reference.

In some aspects a non-ionic photoactivatable crosslinking agent can beused. In one embodiment, the non-ionic photoactivatable crosslinkingagent has the formula XR1R2R3R4, where X is a chemical backbone, and R1,R2, R3, and R4 are radicals that include a latent photoreactive group.Exemplary non-ionic crosslinking agents are described, for example, inU.S. Pat. Nos. 5,414,075 and 5,637,460 (Swan et al., “RestrainedMultifunctional Reagent for Surface Modification”). Chemically, thefirst and second photoreactive groups, and respective spacers, can bethe same or different.

In other embodiments, the non-ionic photoactivatable crosslinking agentcan be represented by the formula:PG2-LE2-X-LE1-PG1

wherein PG1 and PG2 include, independently, one or more photoreactivegroups, for example, an aryl ketone photoreactive group, including, butnot limited to, aryl ketones such as acetophenone, benzophenone,anthraquinone, anthrone, anthrone-like heterocycles, their substitutedderivatives or a combination thereof; LE1 and LE2 are, independently,linking elements, including, for example, segments that include urea,carbamate, or a combination thereof; and X represents a core molecule,which can be either polymeric or non-polymeric, including, but notlimited to a hydrocarbon, including a hydrocarbon that is linear,branched, cyclic, or a combination thereof; aromatic, non-aromatic, or acombination thereof; monocyclic, polycyclic, carbocyclic, heterocyclic,or a combination thereof; benzene or a derivative thereof; or acombination thereof. Other non-ionic crosslinking agents are described,for example, in Publ. No. U.S. 2012/0149934 (to Kurdyumov,“Photocrosslinker”), the disclosure of which is incorporated herein byreference.

Further embodiments of non-ionic photoactivatable crosslinking agentscan include, for example, those described in US Pat. Publication2013/0143056 (Swan et al., “Photo-Vinyl Linking Agents”), the disclosureof which is incorporated herein by reference. Exemplary crosslinkingagents can include non-ionic photoactivatable crosslinking agents havingthe general formula R1-X—R2, wherein R1 is a radical comprising a vinylgroup, X is a radical comprising from about one to about twenty carbonatoms, and R2 is a radical comprising a photoreactive group.

A single photoactivatable crosslinking agent or any combination ofphotoactivatable crosslinking agents can be used in forming the coating.In some embodiments, at least one nonionic crosslinking agent such astetrakis(4-benzoylbenzyl ether) of pentaerythritol can be used with atleast one ionic crosslinking agent. For example, at least one non-ionicphotoactivatable crosslinking agent can be used with at least onecationic photoactivatable crosslinking agent such as anethylenebis(4-benzoylbenzyldimethylammonium) salt or at least oneanionic photoactivatable crosslinking agent such as4,5-bis(4-benzoyl-phenylmethyleneoxy)benzene-1,3-disulfonic acid orsalt. In another example, at least one nonionic crosslinking agent canbe used with at least one cationic crosslinking agent and at least oneanionic crosslinking agent. In yet another example, a least one cationiccrosslinking agent can be used with at least one anionic crosslinkingagent but without a non-ionic crosslinking agent.

An exemplary crosslinking agent is disodium4,5-bis[(4-benzoylbenzyl)oxy]-1,3-benzenedisulfonate (DBDS). Thisreagent can be prepared by combining4,5-Dihydroxylbenzyl-1,3-disulfonate (CHBDS) with4-bromomethylbenzophenone (BMBP) in THF and sodium hydroxide, thenrefluxing and cooling the mixture followed by purification andrecrystallization (also as described in U.S. Pat. No. 5,714,360,incorporated herein by reference).

Further crosslinking agents can include the crosslinking agentsdescribed in U.S. Pat. No. 8,779,206 (to Guire et al.) U.S. Pat. No.8,487,137 (to Guire et al.) and U.S. Pat. No. 7,772,393 (to Guire etal.) the content of all of which is herein incorporated by reference.

In some embodiments, crosslinking agents can include boron-containinglinking agents including, but not limited to, the boron-containinglinking agents disclosed in U.S. Pat. No. 9,410,044 (to Kurdyumov) thecontent of which is herein incorporated by reference. By way of example,linking agents can include borate, borazine, or boronate groups andcoatings and devices that incorporate such linking agents, along withrelated methods. In an embodiment, the linking agent includes a compoundhaving the structure (I):

wherein R1 is a radical comprising a photoreactive group; R2 is selectedfrom OH and a radical comprising a photoreactive group, an alkyl groupand an aryl group; and R3 is selected from OH and a radical comprising aphotoreactive group. In some embodiments the bonds B—R1, B—R2 and B—R3can be chosen independently to be interrupted by a heteroatom, such asO, N, S, or mixtures thereof.

Additional agents for use with embodiments herein can includestilbene-based reactive compounds including, but not limited to, thosedisclosed in U.S. Pat. No. 8,487,137, entitled “Stilbene-Based ReactiveCompounds, Polymeric Matrices Formed Therefrom, and ArticlesVisualizable by Fluorescence” by Kurdyumov et al., the content of whichis herein incorporated by reference.

Additional photoreactive agents, crosslinking agents, hydrophiliccoatings, and associated reagents are disclosed in U.S. Pat. No.8,513,320 (to Rooijmans et al.); U.S. Pat. No. 8,809,411 (to Rooijmans);and 2010/0198168 (to Rooijmans), the content of all of which is hereinincorporated by reference.

Natural polymers can also be used to form the hydrophilic layer. Naturalpolymers include polysaccharides, for example, polydextrans,carboxymethylcellulose, and hydroxymethylcellulose; glycosaminoglycans,for example, hyaluronic acid; polypeptides, for example, solubleproteins such as collagen, albumin, and avidin; and combinations ofthese natural polymers. Combinations of natural and synthetic polymerscan also be used.

In some instances a tie layer can be used to form the hydrophilic baselayer. In yet other instances the tie layer can be added to thehydrophilic base layer. The tie layer can act to increase the adhesionof the hydrophilic base layer to the substrate. In other embodiments,the tie layer can act to increase adhesion of the hydrophobic activeagent to the hydrophilic base layer. Exemplary ties layers include, butare not limited to silane, butadiene, polyurethane and parylene. Silanetie layers are described in US Patent Publication 2012/0148852 (toJelle, et al.), the content of which is herein incorporated byreference.

In exemplary embodiments, the hydrophilic base layer can include tannicacid, polydopamine or other catechol containing materials.

In some embodiments of the present disclosure medicaments (e.g.,bioactive agents) can be coated on devices herein. Additionally,excipients can be coated on devices herein to provide improved in vivotransfer characteristics of medicaments. Materials and devices fordelivery of medicaments are described in U.S. Pat. Publications2015/0140107 and 2012-0296274 (both to Slager), the content of both ofwhich are herein incorporated by reference.

It should be noted that, as used in this specification and the appendedclaims, the singular forms “a,” “an,” and “the” include plural referentsunless the content clearly dictates otherwise. Thus, for example,reference to a composition containing “a compound” includes a mixture oftwo or more compounds. It should also be noted that the term “or” isgenerally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

It should also be noted that, as used in this specification and theappended claims, the phrase “configured” describes a system, apparatus,or other structure that is constructed or configured to perform aparticular task or adopt a particular configuration to. The phrase“configured” can be used interchangeably with other similar phrases suchas arranged and configured, constructed and arranged, constructed,manufactured and arranged, and the like.

All publications and patent applications in this specification areindicative of the level of ordinary skill in the art to which thisinvention pertains. All publications and patent applications are hereinincorporated by reference to the same extent as if each individualpublication or patent application was specifically and individuallyindicated by reference.

Aspects have been described with reference to various specific andpreferred embodiments and techniques. However, it should be understoodthat many variations and modifications may be made while remainingwithin the spirit and scope herein.

The invention claimed is:
 1. A device for vascular access hemostasis,the device comprising: an enclosure configured to at least partiallyreceive a medical device, the enclosure defining a cavity and having afirst seal portion; and a second seal portion, the cavity disposedbetween the first seal portion and the second seal portion; a barrel instructural communication with the second seal portion; the second sealportion comprising a septum seal; the second seal portion defining threeor more discrete portions each separated from one another by one or moresplit lines, the discrete portions each comprising a mating surfaceconfigured to interface with mating surfaces of other discrete portions,the mating surface comprising a surface topology including a pluralityof raised portions and depressions.
 2. The device of claim 1, the firstseal portion comprising an inwardly sloped portion, the inwardly slopedportion comprising an outer surface, further comprising a hydrophiliclayer disposed on the outer surface.
 3. The device of claim 2, theinwardly sloped portion forming a frustoconical shape.
 4. The device ofclaim 1, further comprising a hydrophilic layer disposed on the matingsurfaces of each discrete portion.
 5. The device of claim 1, the raisedportions and depressions comprising regular pattern of peaks andvalleys.
 6. The device of claim 1, the peaks and valleys having a pitchof about 0.01 mm to about 1.0 mm.
 7. The device of claim 1, a verticaldistance between the top of peaks and the bottom of valleys comprisingabout 0.01 mm to about 1.0 mm.
 8. The device of claim 1, wherein the oneor more splits have a depth sufficient to pass through the barrel andthe septum seal, but not through the entire enclosure.
 9. The device ofclaim 1, further comprising support ribs operably connected to thesecond seal portion, wherein the support ribs are configured forcompressive interfacing with a housing.
 10. The device of claim 1,wherein the first seal portion comprises a hole seal.
 11. The device ofclaim 1, wherein the first seal portion comprises a ring seal.
 12. Thedevice of claim 1, wherein the second seal portion is configured to beheld in compression by a mating housing.
 13. The device of claim 1,wherein the mating surface comprises a portion having the surfacetopology including the plurality of raised portions and depressions andcomprising a portion that is substantially flat.
 14. A sealing devicecomprising: a device enclosure defining a cavity, wherein the deviceenclosure is configured to compressively interface with a housing; afirst seal portion in communication with the device enclosure, the firstseal portion defining an opening; and a second seal portion incommunication with the device enclosure; and the second seal portiondefining three or more discrete portions separated from one another by asplit along a split plane, the discrete portions each comprising amating surface to interface with mating surfaces of other discreteportions, the mating surface comprising a surface topology including aplurality of raised portions and depressions.
 15. The sealing device ofclaim 14, the device enclosure comprising a plurality of support ribs incompressive communication with the second seal portion.
 16. The sealingdevice of claim 14, wherein the support ribs are offset from the splitby about 45 degrees.
 17. The sealing device of claim 14, wherein thesupport ribs are substantially symmetrical relative to the split.
 18. Amethod of making a sealing device comprising: obtaining an enclosureconfigured to at least partially receive a medical device, the enclosuredefining a cavity and having a first seal portion; and a second septumseal portion, the cavity disposed between the first seal portion and thesecond septum seal portion; and forming a split in the second sealportion, the split defining three or more discrete portions eachcomprising a mating surface to interface with mating surfaces of otherdiscrete portions, the mating surface comprising a surface topologyincluding a plurality of raised portions and depressions.